NCT06968221 Bovine Reinforcement in Stomach, Colorectal and Lung Operation
| NCT ID | NCT06968221 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Cingularbio Co. Ltd |
| Condition | Rectal Cancer Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-09-01 |
Trial Parameters
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Brief Summary
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced techniques with respect to the incidence of postoperative hemorrage rate, anastomotic leakage, if applicable.
Eligibility Criteria
Inclusion Criteria: * Subjects who will undergo operation with stapled stomach, colorectal anastomosis with or without reinforcement * Subjects willing to accept informed consent and willing to attend the follow up Exclusion Criteria: * Subjects who have significant intraoperative hypotension or cardiac events. * Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values). * Subjects have uncontrolled intra-abdominal infection
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